None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Add-on application of MSC-based medicinal product (500 ?/?) to osteoarthritic cartilage defect being treated by microfracture
Sponsors
Medicrinia Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who diagnosed as osteoarthritis based on ACR criteria 2. Subjects who are scheduled to undergo microfracture treatment for cartialge defect due to osteoarthritis 3. Kellegren & Lawrence Grade 2-3 4. Arthrscopy confirmed ICRS grade 3 or 4 cartilage lesion 5. No improvement of symptoms by nonoperative treatment for at least 3 months 6. Pain on the target knee > 40 mm on VAS at screening 7. Adults of age 20 or older 8. Major cartilage defect size 2 ? ~ 9 ? at one compartment showing most prominent symptoms 9. More painful knees in case of bilateral knee pain 10. BMI between 18-35 11. No clinically significant abnormal findings in physical exam, blood lab tests, and urine lab tests 12. Female subjects who consented to contraception during the Part I study period 13. Subjects who are willing to participate in this study and signed the informed consent form
Exclusion criteria
Exclusion criteria: 1. BMI =35?/? at screening visit 2. Taking psychotropic substance or opioid pain killer for the recent 3 months 3. Clinical significant abnormal lab test results at screening 4. Rheumatoid arthritis or other inflammatory or metabolic arthritis 5. Any signs of infection at the target knee or around the joint 6. Secondary arthrtiis due to Ochronosis, Hemochromatosis, or other systemic disease 7. Subjects with significant pain such as Sudeck’s atrophy, Paget’s disease, fibromyalgia, or CRPS 8. Signifcant deformity of the knee due to osteoarthhritis (HKA angle deviation > 10 degree) 9. Subjects with significant pain at other joints(hip, spine, etc) that may affect knee pain 10. Subjects with significant pain at the other knee that the investigator considers inappropriate to be enrolled in this study 11. Administraion of the below found at screeing visit 1) Hyaluronic acid injection at the target knee or other joint within 6 month 2) Steroid injection at the target knee within 3 months 3) Systemic administration of steroid within 1 month (except inhalant) 12. History of arthroscopic or open surgery at the target knee within 1 year (except arthroscopic examination only) 13. History of replacement surgery at the target knee 14. Subjects who have to use anticoagulant (except low dose aspiring, daily dose less than 300 mg) 15. Grade II or more ligament laxity at the target knee 16. History of allergy to Hyaluronate or Gentamicin 17. Subjects who need to take immunosuppressant or who took immunosuppressant such as Cyclosprin A or Azathioprine within 6 weeks 18. Subjects who had taken other cell therapy product 19. Female subjects who do not agree contraception during the part I trial period 20. Subjects who are pregnant or on breast feeding 21. Subjects participating in another clinical trial in during the trial period 22. Subjects deemed inappropriate by the investigator other than the above items
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse reactions;Symptom improvement assessed by KOOS at 48 weeks compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of cartilage repair at the defect site;Dose limiting toxicity | — |
Countries
Korea, Republic of
Contacts
Public ContactYong In
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed